A Safety Study of GAMMAGARD LIQUID (GGL) in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

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Brief Title

A Safety Study of GAMMAGARD LIQUID (GGL) in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Official Title

Evaluating the Safety of GAMMAGARD LIQUID for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Brief Summary

      The main aim of this study is to evaluate the rates of adverse events of special interest
      (AESIs) (thrombotic events, acute kidney injury [AKI], and hemolytic events) among
      participants with CIDP initiating GGL compared with rates among participants with CIDP
      initiating comparator intravenous immunoglobulin (IVIG) products.

      No study medicines will be provided to participants in this study.
    



Study Type

Observational


Primary Outcome

Number of Participants With Thrombotic Events (TEs)

Secondary Outcome

 Number of Participants With Anaphylaxis

Condition

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)


Study Arms / Comparison Groups

 Ig-naive (New-to-class) Cohort
Description:  Participants who initiate GGL or one of the comparator IVIG products who have no record of previous use of any Ig product (Ig naive) for at least 6 months before study initiation will be include in this cohort.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

7000

Start Date

May 28, 2022

Completion Date

March 31, 2023

Primary Completion Date

March 31, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Have a minimum of 6 months of continuous enrollment in the study database with medical
             and pharmacy coverage before the index date. Gaps in continuous enrollment less than
             or equal to (<=) 31 days are permitted.

          -  Fulfill the Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) diagnosis
             algorithm on or before the index date using all available baseline data for each
             participant.

          -  Additionally, to be eligible for the Ig-naive (new-to-class) cohort, participants will
             be required to meet the following inclusion criterion:

          -  Be free of any previous recorded use of any Ig product at any point before IVIG
             initiation.

          -  To be eligible for the Ig-experienced (new-to-drug) cohort, participants will be
             required to meet the following inclusion criterion:

          -  Have any previous recorded use of an Ig product at any point before the index date.

        Exclusion Criteria:

          -  Having claims for greater than or equal to (>=) 2 different IVIG products on the index
             date.

          -  Recorded diagnosis of any of the following conditions where Ig products are used for
             treatment on or before the index date

               1. Primary immunodeficiency disease (PID).

               2. Evidence of secondary immunodeficiency (SID), including hematological malignancy
                  (e.g., diagnosis of multiple myeloma or chronic lymphocytic leukemia) or
                  treatment with rituximab.

               3. Idiopathic thrombocytopenic purpura (ITP).

               4. Dermatomyositis or polymyositis.

               5. Systemic sclerosis/scleroderma.

               6. Myasthenia gravis.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Study Director, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05363358

Organization ID

TAK-771-4002

Secondary IDs

EUPAS46101

Responsible Party

Sponsor

Study Sponsor

Takeda

Collaborators

 Baxalta Innovations GmbH, now part of Shire

Study Sponsor

Study Director, Study Director, Takeda


Verification Date

June 2022